Medical Director, Pathologist
Bio-Techne’s Advanced Cell Diagnostics, Inc. (ACD) is a leader in the field of molecular pathology and tissue-based diagnostics. Our core RNAscope® technology is the world’s first multiplex fluorescent and chromogenic in situ hybridization platform capable of detecting and quantifying RNA biomarkers in situ at single molecule sensitivity. RNAscope® is an ideal platform for developing the next generation of tissue-based diagnostics. We are committed to continued innovation to bridge the gap between basic research and clinical medicine to fulfill the promise of personalized medicine.
Salary Range: $280K-380K depending on experience
POSITION DESCRIPTION
The Medical Director, Pathologist will serve key roles for the Spatial Biology Division (SBD) in clinical product development (including Dx and CDx), collaboration with sales and marketing to support commercialization of clinical products, service as a clinical consultant for pathologists using RNAscope products, education of customers on the use of RNAscope and related technologies (including at conferences), collaboration with key opinion leaders to develop new clinical applications, and provision of subject matter expertise for clinical and diagnostic projects, including projects managed by Professional Assay Services (PAS), a service arm of SBD.
KEY RESPONSIBILITIES:
- Build and grow collaborative relationships with cross-functional teams to advance clinical products and diagnostics within the company.
- Provide insight and strategic direction into new clinical product development and innovation opportunities, including new probes, detection technologies, and automation, actively participating in prioritization of opportunities based on clinical value and strong medical understanding of physician and patient needs.
- Provide medical input to clinical product risk assessments, adverse event review, and regulatory body interactions (eg. FDA).
- Participate in decision making process and regulatory strategy for IVD applications.
- Provide external education and expertise to support market adoption of RNAscope technologies in a variety of settings, including conferences, webinars, and site visits.
- Drive the identification and cultivation of key external experts to provide insights and inform new applications and products.
- Develop partnerships and collaborations with KOLs and academic pathologists to generate evidence in support of new and existing products.
- Support development and execution of clinical studies for regulatory projects including FDA 510k/PMA, IVDR, and CDx including participation in study design, scoring guide development, external pathologist training and other key medical activities.
- Serve as key member of CDx project teams, supporting all aspects of CDx assay development including support of commercial partners such as Leica Biosystems.
- Engage internal teams and pharma partner teams on a wide variety of clinical, medical and scientific discussions related to CDx development.
OCCASIONAL DUTIES AND RESPONSIBILITIES:
- Training of internal teams on clinical applications of RNAscope and related technologies.
- Pathology case review and scoring for clinical studies and Professional Assay Services projects.
- Provision of medical insight and support of diagnostic projects in other divisions and/or cross-divisional projects.
QUALIFICATIONS:
- MD with Anatomic Pathology (AP) board certification (active medical license not required)
- Understanding of anatomic pathology research, practice, and market landscape
- Experience with advanced staining techniques including IHC, RNA ISH, DNA ISH/FISH
- Familiarity with clinical practice of pathology, biomarker technologies, and vision of future trends in pathology practice
- Team player with professional presence and demeanor coupled with superb written and verbal communication skills.
- Creative thinker with excellent problem-solving and decision-making skills
PREFERRED QUALIFICATIONS:
- Board Certification in Clinical Pathology (CP) and/or pathology subspecialty such as molecular genetic pathology, hematopathology, or cytopathology
- MS or PhD in a scientific discipline with advanced scientific training and experience, with track record of quality publications.
- >2 years post-residency experience in the practice of pathology in a community or academic setting
- >2 years of industry pathology experience following completion of pathology training
- Knowledge of laboratory regulations (CAP/CLIA), billing, and reimbursement
- Prior experience with FDA (510k or PMA) and/or other regulatory agencies
Why Join Bio-Techne:
- We offer competitive salaries along with extensive medical, vision, and dental plans for you and your family starting on day one!
- We invest in our employees’ financial futures through 401k matching and an employee stock purchase plan.
- We help our employees develop their careers through mentorship, promotional opportunities, training and development, internship programs, tuition reimbursement, and more.
- We offer employee resource groups, volunteer paid time off, employee events, and charity drives to build a culture of caring and belonging.
- We foster a culture of empowerment and innovation, where employees feel valued and encouraged to bring their new ideas to the table.
Where permitted by applicable law, candidate must have received or be willing to receive an FDA authorized COVID-19 vaccine by date of hire to be considered for this position.
Bio-Techne is an E-Verify Employer in the United States.